We map your workflows in their real organizational context, identify where AI can genuinely move the needle, and deliver a prioritized set of use cases with realistic build paths, effort estimates, and a clear definition of success.
How discovery worksAI-driven life sciences transformation
Governance-first AI for regulated life sciences.
Senior-led advisory and software for pharmacovigilance, clinical operations, and regulatory affairs: AI that is auditable by design, governed by experts, and deployed with the rigor your inspectors expect.
- EU AI Act high-risk posture
- ISO/IEC 42001 AI management
- 21 CFR Part 11 & Annex 11
- CIOMS AI in pharmacovigilance
Our thesis
In regulated science, governance is not the brake on AI adoption: it is the enabler.
The conservatism of pharmacovigilance is rational: you have to prove a system before you trust it. We treat that as the design starting point, not an afterthought.
Teams that build audit-ready infrastructure first are the ones that deploy faster, pass inspection, and earn the confidence of health authorities. That is the work we do.
How we work
Three connected phases.
Clients may enter at any point, but the structure holds: understand the opportunity, demonstrate it on our environment, deploy it safely in yours.
We build a working system end-to-end on our environment and show you the outcome before your team commits to deployment: develop, test, review, establish, finalize, against your real use case.
See the demo phaseWe deploy into your environment with the compliance discipline regulated work demands: GxP and 21 CFR Part 11 alignment, audit-trail and explainability design, PII governance, role-based access, and human-in-the-loop control.
Inside deploymentFlagship product
SDI: Safety Decision Intelligence.
An intelligence layer that sits above your validated safety systems. SDI ingests safety documents and data across sources, performs structured assessment, and produces audit-ready outputs for health-authority requests and signal evaluation, replacing uncontrolled tooling with traceable, reproducible work.
Capabilities
- Document summarization
- Signal intelligence & assessment
- Narrative & case-prep support
What it produces
- Defensible HA responses
- Signal summaries
- Consistent ICSR narratives
Track record
Two decades of senior R&D experience, applied to AI in regulated environments.
Client outcomes
What deployment delivers.
- Faster insight generation from safety and regulatory documents
- Earlier signal identification across PV data sources
- Audit-ready outputs that hold up to inspection
- Operational efficiency at human-in-the-loop scale
- Regulatory readiness across jurisdictions and products
- Expert capacity redirected to expert judgment
Areas of expertise
Where regulatory, technical, and operating knowledge meet.
- Pharmacovigilance & safety operations
- Clinical operations & trial conduct
- Regulatory affairs & submission readiness
- GxP & 21 CFR Part 11 validation
- ISO/IEC 42001 AI management systems
- EU AI Act risk classification
- Audit trail & explainability design
- PII handling & data governance
- Model risk management
- Human-in-the-loop architecture
Leadership
Senior expertise, hands-on.
A senior-led alternative to large firms and their handoff structures. The advisor who scopes your engagement does the work.

Arvind Bellur
Founder & Principal
A career spanning life sciences R&D and technology transformation. Arvind founded Altio Advisory to deliver focused, senior advisory in an industry over-served by junior generalists, grounded in pharmacovigilance operations, clinical platforms, regulatory technology, and AI-enabled operating-model design at global pharma scale.

Evren Yucekus-Kissane
AI Architect & Researcher
Specializes in machine learning, generative AI, and analytics-platform design, with prior roles at Sanofi and CSL building architectures for scientific use cases. Founded the AI and quantum-computing research program at the University of Maryland; focused on AI/ML system architecture for regulated environments.